510(k) K992895
K992895 is an FDA 510(k) premarket notification submitted by Espe Dental AG for the device "IMPREGUM F". The FDA issued a decision of Substantially Equivalent on September 8, 1999. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Espe Dental AG has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 8, 1999
- Date Received
- August 27, 1999
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Material, Impression
- Device Class
- Class II
- Regulation Number
- 872.3660
- Review Panel
- DE
- Submission Type